Current Edition

Keeping track of traceability preparing for the
Volume 10 Issue 2

Keeping Track of Traceability – Preparing for the EU Medical Device Regulation

Under the FDA (Food & Drug Administration) rule in the USA, manufacturers have been required to implement UDI (unique device identification) on all medical product …

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Regulatory trends and developments in the
Volume 10 Issue 2

Regulatory Trends and Developments in the Pharmaceutical Industry in 2018

In the 2017 fiscal year, the FDA issued 114 warning letters to pharmaceutical manufacturers contravening Current Good Manufacturing practices (cGMPs). This followed a trend of …

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Navigating risk management plans
Volume 10 Issue 2

Navigating Risk Management Plans (RMPs) in the Evolving Regulatory Landscape

Pharmacovigilance (PV) is a vital part of healthcare and for monitoring the benefit-risk profile of medicinal products. The purpose of the European Medicines Agency’s (EMA’s) …

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Strategies adopted by branded drug
Volume 10 Issue 2

Strategies Adopted by Branded Drug Manufacturers against Para IV Filers

This article by Trishna Chetry, T.M. Pramod Kumar, M.P. Venkatesh and Balamuralidhara V. from JSS College highlights the complex and critical regulatory strategies adopted by …

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Trends in drug development in denmark and globally
Volume 10 Issue 2

Trends in Drug Development – In Denmark and Globally

The entire process from discovering and developing a potential drug candidate to its delivery into the human body requires comprehensive knowledge about the root cause of …

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Model system for studying the human gut microbiome
Volume 10 Issue 2

Model Systems for Studying the Human Gut Microbiome

A variety of in vivo, in silico, in vitro, and ex vivo model systems are available to researchers for studying the human intestinal microbiome, its …

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Brown adipose tissue as a therapeutic model
Volume 10 Issue 2

Brown Adipose Tissue as a Therapeutic Model for Obesity Treatment

Obesity is a major concern for governments worldwide. In the UK alone, it is estimated that the direct costs of obesity to the National Health …

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HBP biomarkers and assay development
Volume 10 Issue 2

HBP Biomarkers and Assay Development within Laboratory Practice

“Sepsis is the most preventable cause of death”, and every hour it is not diagnosed will increase the probability it will kill the patient by …

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iPSC models to improve efficiency
Volume 10 Issue 2

iPSC Models to Improve Efficiency of Drug Discovery and Development

Stem cells attract a great deal of attention due to their developmental potential and lineage-independent characteristics. Adult stem cells, otherwise known as inducible pluripotent stem …

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Novel drug based strategies for cardiac
Volume 10 Issue 2

Novel Drug-based Strategies for Cardiac Regeneration Following Myocardial Infarction

The human heart is one of nature’s engineering marvels, considering the requirement specifications for this fist-sized hollow organ that only weighs 250–300 grams. Delivering about …

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